NCT00418457.

Trial name or title	Regional anaesthesia and breast cancer recurrence: prospective, randomized, double‐blinded, multicenter clinical trial to compare postoperative analgesia and cancer outcome after combined paravertebral versus thoracic epidural versus general anaesthesia for breast cancer surgery
Methods	Prevention, randomized, open‐label, active‐control, parallel‐assignment, efficacy study
Participants	Ages eligible for study: 18‐85 years Genders eligible for study: women only Estimated enrolment: 1600 Women undergoing mastectomies or isolated lumpectomy with axillary node dissection
Interventions	Combined paravertebral vs thoracic epidural vs general anaesthesia
Outcomes	Primary outcome is cancer recurrence with a follow‐up of 5 years. Secondary outcomes include chronic pain, among others, with a follow‐up of 6 and 12 months
Starting date	January 2007
Contact information	Nancy Graham, RN        Tel: +1216‐445‐7530     e‐mail: grahamn@ccf.org
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